Antibacterial pro-coagulant formula

ABSTRACT

The disclosed invention provides an antibacterial pro-coagulant formula for assisting in combating the condition of bleeding gums caused by periodontal disease and gingivitis that enhances the natural healing process by assisting in the of cessation of bleeding by providing an “anti-bacterial oral healing environment” accompanied by enhanced blood flow to the affected bleeding area for more rapid blood clotting and increased blood flow to the affected area to assist the body&#39;s natural process of rebuilding healthy gum-tissue. Additionally, the disclosed invention with its antibacterial benefits, when used topically, provides for rapid surface skin blood clotting as well as increased blood circulation on the skin surface which greatly aids in the healing of external skin cuts, such as nicks from shaving or against inflammation of the skin from acne vulgaris. Continued use of the product orally and topically has proven to provide a beneficial stability to overall oral and skin health, especially useful in promoting healing in high-bacterial environments, such as is common in a person&#39;s mouth or on their face. Further described is a method of promoting hair follicle growth by application of the presented invention to a human scalp to promote blood flow to the scalp through below skin surface blood vessel dilation and below surface anti-bacterial cleansing of the scalp effecting an unrestricted and healthy skin tissue environment conducive to promoting hair follicle re-growth.

STATEMENT OF FEDERALLY SPONSORED RESEARCH

N/A

FIELD OF INVENTION

The presented invention relates to oral care and more specifically to anantibacterial pro-coagulant composition for gum care and for use in thetreatment of gingivitis, bleeding gums, gum inflammation and periodontaldisease. Additionally, the invented formula provides a breakthrough inthe field of topical treatments for acne, skin rejuvenation, insect biterelief and first aid for stopping bleeding from razor nicks. Furtherdescribed is a method of promoting hair follicle growth by applicationof the presented invention to a human scalp to promote blood flow to thescalp through below skin surface blood vessel dilation and below surfaceanti-bacterial cleansing of the scalp effecting an unrestricted andhealthy skin tissue environment conducive to promoting hair folliclere-growth.

BACKGROUND OF THE INVENTION

Dental plaque is a sticky biofilm or a mass of bacteria that is commonlyfound between the teeth, along the gumline, and below the gumlinemargins. Dental plaque can give rise to dental caries and periodontalproblems, such as gingivitis and periodontitis. In the early stages,periodontitis has very few symptoms, and in many individuals the diseasehas progressed significantly before they seek treatment. Symptoms mayinclude redness or bleeding of gums while brushing teeth, using dentalfloss or biting into hard food. Other symptoms include gum-swelling thatrecurs, spitting out blood after brushing teeth, halitosis, or badbreath, and a persistent metallic taste in the mouth. Deep-pocketsbetween the teeth and the gums, and loose teeth occur in the laterstages.

Deep teeth-cleaning, also referred to as root planing or scaling, is aprocedure carried out by a dental hygienist to treat periodontal and gumdisease. The scaling process scrapes away bacterial plaque and tartarfrom the tooth. Sometimes, deep teeth-cleaning results in or furthersinflammation of the gums. In a regular cleaning, scaling is performed onthe part of the tooth that is exposed above the gumline.

A deep-cleaning is a periodontal procedure used to treat early-stageperiodontal (gum) disease. A dentist, periodontist (gum specialist), ordental hygienist removes the plaque through a deep-cleaning method thatcombines scaling and root planing. Scaling is performed above and belowthe gumline to remove plaque and tartar. Root planing gets rid of roughspots on the tooth where germs gather, and helps remove bacteria thatcontribute to gum disease.

Although deep-cleaning is effective at removing plaque buildup, it doesnot eliminate all the bacteria that cause gum disease. Currently, whennecessary, treatment may also include placing medication such as Arestinor Perio-Chip into gum pockets if the pocket is greater than 4 mm. Inthat case, patients are advised to postpone brushing for 12 hours andavoid the use of inter-proximal cleaning devices (flossing) for 10 days.

It is this recovery period of time after periodontal treatment in which,due to the inflammation and open wounds caused by the deep-cleaningprocedure itself, that a “bacteria free” healing environment is neededfor natural gum healing. All too often, the patient fails to achievelasting results due to the fact that there has not been, until now, aworkable system to provide a “bacteria-free enough” and healthy enoughoral environment, long enough, to allow the gums a chance to healnaturally.

It would be similar to having an open wound on the body. If it were openand bleeding, and it was not allowed to go through the natural healingstages of the cessation of bleeding, followed by the healing of theinflammation and then onto its healthy tissue re-growth stage, (due tothe open wound being in a wet environment under constant bacterialattack, like the environment gums are exposed to after periodontaltreatment), of course the healing process itself, would, at best, be asource of further health and healing complications due to infection,protracted exposure to the bacterial environment, as well as beingpainful to the patient.

The presented invention with its active indigents combined andadministered as described herein, has exceptional anti-bacterial,anti-inflammatory, and deep-cleansing benefits on patients who recentlyhad their teeth professionally deep-cleaned by a dentist or hygienist.The presented invention provides a breakthrough anti-bacterial andpro-coagulant “oral healing environment” that is greatly efficacious inthe restoration of gums from a periodontal “emergency state” of bleedinggums, to a reinstated natural healthy condition that provides thedesired “fresh start”, so many of today's periodontists, dentists andhygienists are desiring for their trusting oral care patients.

4 Main Gum Healing Phases:

Gum healing can be divided into 4 overlapping phases: Hemostasis,Inflammatory, Proliferative and Maturity

Phase 1: Hemostasis Phase

Hemostasis, the first phase of healing, could be said to begin at theonset of injury, and the objective is to stop the bleeding. In thisphase, the body activates its emergency repair system, namely the bloodclotting system, and forms a dam to block the drainage. During thisprocess, platelets come into contact with collagen, resulting inactivation and aggregation. An enzyme called thrombin is at the center,and it initiates the formation of a fibrin mesh, which strengthens theplatelet clumps into a stable clot.

Phase 2: Defensive/Inflammatory Phase

Phase 1 is primarily about coagulation, the second phase, could becalled the Defensive/Inflammatory Phase and it focuses on destroyingbacteria and removing debris-essentially preparing the wound bed for thegrowth of new tissue.

During Phase 2, a type of white blood cells called neutrophils enter thewound to destroy bacteria and remove debris. These cells often reachtheir peak population between 24 and 48 hours after injury, reducinggreatly in number after three days. As the white blood cells leave,specialized cells called macrophages arrive to continue clearing debris.These cells also secrete growth factors and proteins that attract immunesystem cells to the wound to facilitate tissue repair. This phase oftenlasts four to six days and is often associated with edema, erythema(reddening of the skin), heat and pain.

Phase 3: Proliferative Phase

Once the wound is cleaned out, the wound could b e said to enter Phase3, the Proliferative Phase, where the focus is to fill and cover thewound.

The Proliferative phase features three distinct stages: 1) filling thewound; 2) contraction of the wound margins; and 3) covering the wound(epithelialization).

During the first stage, shiny, deep red granulation tissue fills thewound bed with connective tissue, and new blood vessels are formed.During contraction, the wound margins contract and pull toward thecenter of the wound. In the third stage, epithelial cells arise from thewound bed or margins and begin to migrate across the wound bed inleapfrog fashion until the wound is covered with epithelium.

Phase 4: Maturation Phase

During the Maturation phase, the new tissue slowly gains strength andflexibility. Here, collagen fibers reorganize, the tissue remodels andmatures and there is an overall increase in tensile strength (thoughmaximum strength is limited to 80% of the pre-injured strength). TheMaturation phase varies greatly from wound to wound, often lastinganywhere from 21 days to two years.

The healing process is remarkable and complex, but it is alsosusceptible to interruption due to local and systemic factors, includingmoisture, bacterial infection, and maceration.

The presented invention when used as described herein provides a greatlyimproved antibacterial and pro-coagulant healing environment due toincreased blood circulation and improved clotting to more a rapidlyassist the body through the 4 main healing phases to heal and replacedevitalized gum and skin tissue.

BRIEF SUMMARY

Disclosed herein is an anti-bacterial and pro-coagulant composition thatincludes (a) (NIACIN) Pyridine-3-Carboxylic Acid, (b) (HYDROGENPEROXIDE) and optionally (c) Dihydrogen Dioxide, (DISTILLED WATER)Dihydrogen Oxide, potable water or purified water, (d) (CALCIUM) Calcium7440-70-2 and optionally (e) (VITAMIN D3) Cholecalciferol. In someembodiments, the oral and topical care antibacterial pro-coagulantcomposition can be in the form of a liquid, paste, gel, spray, gum orother excipient.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the disclosure, are intended forpurposes of illustration only and are not intended to limit the scope ofthe disclosure.

SUMMARY

Hydrogen Peroxide kills bacteria by oxidizing their cell walls, stealingelectrons from them and disrupting their chemical structures. Niacin isrequired for the proper function of fats and sugars in the body and tomaintain healthy cells. Niacin also causes the small blood vessels onthe skin and in the gums to dilate so more blood can rush to an areaaffected by skin inflammation, gingivitis or periodontal inflammation orinjury due to dental deep-cleaning tools and procedures. At higherdoses, niacin has beneficial effects on speed of blood clotting. It hasnow been discovered that niacin, when dissolved and placed informulation with hydrogen peroxide, and when used as described herein,is effective in fighting gum-disease, aids in stopping gum-bleeding andgum-inflammation, and can simultaneously provide an effectiveconcentration of Niacin to promote enhanced blood circulation andclotting to the injured or inflamed gum tissue, as well as provide anenhanced anti-bacterial and increased blood flow environment for gumtissue rehabilitation. Optionally used along with the basic inventivecombination of Niacin and Hydrogen Peroxide, as an additional benefit,distilled water can be added which is effective in removing toxins inthe body and is soluble and combines well with Niacin and HydrogenPeroxide. Additionally, Calcium which is beneficial in bone growth andstrength, and vitamin D3 which assists in the body's absorption ofCalcium can also be added as described herein to provide vital buildingblocks for bone-strengthening and natural tissue and bone re-growth.

EXAMPLES OF DENTAL PATIENT USE OF THE PRESENTED INVENTION DURINGPERIODONTAL DISEASE RECOVERY STAGES Phase 1: Hemostasis Phase

When brushing or flossing, if bleeding gums occur, use the currentinvention as follows: add ⅔ parts of current invention and ⅓ partdistilled water to your water jet flossing machine tank. Set pulse ashigh as comfortable and concentrate pulse irrigation on problem gumareas first. Lean over sink and spend the 1st % of the tank drain timeon known deep pocket gum areas, working to get a deep rinse on eachpocket. Next, power rinse along the entire gum-line of both upper andlower gums, both inside and out. When the tank is empty, continue tolean over the sink and allow the presented invention formula to foam outbacteria and particles freely from your mouth. This may foam for sometime, so be patient until foaming ceases. When foaming has subsided,brush teeth and rinse thoroughly after brushing. Repeat daily, in themorning and again at night, until the bleeding phase is cleared.

2: Defensive/Inflammatory Phase

Once the bleeding phase has passed, the presented invention greatlyassists in destroying harmful bacteria and removing deep food debrishelping clear the way for inflamed gums to grow healthy and strong. InPhase 2, add a ½ ratio part of the presented invention formula and ½part distilled to your water jet flossing machine tank. Repeat procedureas in Phase 1.

Phase 3: Proliferative Phase

The presented invention assists in the re-growth of healthy gums byproviding a healthy oral environment which continues to defend againstharmful bacteria growth and assists the body it's natural recoveryprocess. In Phase 3, use ⅓ the presented invention and ⅔^(rds) distilledwater in the water jet flossing machine tank and follow the sameprocedure as Phase 1, and 2 for use.

Phase 4: Maturation Phase

During the Maturation phase, the new tissue slowly gains strength andflexibility. The presented invention assists in the re-growth of healthygums by providing a healthy oral environment by continuing to defendagainst harmful bacteria growth and assists the body's natural recoveryprocess. In Phase 4, use a ratio of ¼ of the presented invention to ¾distilled water in the water jet flossing machine tank and follow thesame procedure as Phase 1, 2, and 3 for use.

DRAWING FIGURES

FIG. 1—shows a human tooth with gums that have receded away from thetooth due to bacterial decay. 1.1 shows a gap between the tooth and 1.2shows bacteria in the gums.

FIG. 2 shows the presented invention filling the gaps with the Niacinand Peroxide formula. 2.1 shows the formula attacking the bacteria, 2.2and 2.3 shows the formula filling the gap and soaking the bacteria ladengun area.

FIG. 3—Shows the now recovered gum structure with the gums grown back tohealthy state. FIG. 3.1 shows the now healthy gums and 3.2 shows thegums now tight against the tooth.

FIG- 4 is an illustration that shows the 4 stages of wound healing. 4.1is the Hemostasis stage. 4.2 is the Inflammatory stage. 4.3 is theProliferative stage and 4.4 is the Remodeling stage.

1. An antibacterial pro-coagulant comprising: (a) Pyridine-3-CarboxylicAcid (Niacin) (B-3) and (b) Dihydrogen Dioxide (Hydrogen Peroxide) 2.The antibacterial pro-coagulant of claim 1 wherein thePyridine-3-Carboxylic Acid (Niacin) is present in a concentration of0.01 wt % to 3.0 wt %, based on the total weight of the antibacterialpro-coagulant.
 3. The antibacterial pro-coagulant of claim 1 wherein theDihydrogen Dioxide (Hydrogen Peroxide) is present in a concentration of97.00 wt % to 99.99 wt %, based on the total weight of the antibacterialpro-coagulant.
 4. The antibacterial pro-coagulant of claim 1, whereinthe concentration ratio of the Pyridine-3-Carboxylic Acid (Niacin) tothe Dihydrogen Dioxide (Hydrogen Peroxide) in the antibacterialpro-coagulant composition is from 1:1000 to 1:1.
 5. The antibacterialpro-coagulant of any preceding claim 1, further comprising DihydrogenOxide (Distilled Water), or optionally (potable, high PH or purifiedwater).
 6. The antibacterial pro-coagulant of claim 5, wherein theDihydrogen Oxide (Distilled Water) or optionally (potable, high PH orpurified water is present in the antibacterial pro-coagulant compositionin a concentration of 0.1 wt % to 75 wt %, based on the total weight ofthe antibacterial pro-coagulant.
 7. The antibacterial pro-coagulant ofany preceding claim 1, further comprising either calcium carbonate orcalcium citrate.
 8. The antibacterial pro-coagulant of claim 7, whereinthe calcium carbonate or calcium citrate is present in the antibacterialpro-coagulant composition in a concentration of 0.001 wt % to 3 wt %,based on the total weight of the antibacterial pro-coagulant.
 9. Theantibacterial pro-coagulant of any preceding claim 1, further comprisingVitamin D-3.
 10. The antibacterial pro-coagulant of claim 9, wherein theVitamin D-3. is present in the antibacterial pro-coagulant compositionin a concentration of 0.001 wt % to 3 wt %, based on the total weight ofthe antibacterial pro-coagulant.
 11. The antibacterial pro-coagulant ofany preceding claim 1, further comprising a food grade acidic agent,such as, distilled white vinegar or apple cider vinegar, with an aciditylevel of 4-6%.
 12. The antibacterial pro-coagulant of claim 11, whereinthe food grade acidic agent, such as, distilled white vinegar or applecider vinegar, with an acidity level of 4-6%. is present in theantibacterial pro-coagulant composition in a concentration of 0.01 wt %to 15 wt %, based on the total weight of the antibacterialpro-coagulant.
 13. In accordance with claim 1, the anti-bacterialpro-coagulant suspended in an excipient medium in the form of a liquid,paste, gel, spray, gum, bandage or application stick.
 14. In accordancewith claim 1, the antibacterial pro-coagulant further comprising: (a)Pyridine-3-Carboxylic Acid (Niacin) (B-3), (b) Dihydrogen Dioxide(Hydrogen Peroxide), (c) Dihydrogen Oxide (distilled water) oroptionally (Potable, high PH or purified water) and (d) optionally,orally-acceptable excipients.
 15. In accordance with claim 1, an oralantibacterial pro-coagulant composition based on its weight comprisingfrom (a) about 0.01% to about 5% weight of Niacin (B-3) and (b) based onits weight, 99.99% to about 95% of 3% by volume of hydrogen peroxide inpurified water.
 16. In accordance with claim 1, an oral antibacterialpro-coagulant composition in a 32 fluid ounce by volume containerfurther comprising: (a) between 50 milligrams and 5,000 milligrams ofNiacin (B-3) dissolved into about (b) 16 fluid ounces of 3% by volumehydrogen peroxide in purified water, and (c) further dissolved intoabout 16 fluid ounces of (c) Dihydrogen Oxide (distilled water) oroptionally potable, high PH or purified water for a total 32 fluid oz.volume comprised of (a), (b) and (c) or (d) in a 32 fluid ounce volumecontainer.
 17. In accordance with claim 1, an oral antibacterialpro-coagulant composition in a 32 fluid ounce by volume containerfurther comprising: (a) between 50 milligrams and 5,000 milligrams ofNiacin (B-3) dissolved in about (b) 16 fluid ounces, of 3% by volume ofhydrogen peroxide in purified water, and (c) further dissolved intoabout 12 fluid ounces of (c) Dihydrogen Oxide (distilled water) oroptionally high PH or purified water, (d) optionally, orally acceptableexcipients (e) 1000 mg. of calcium carbonate, and (f) 175 IU of VitaminD-3 further dissolved into (g) about 4 fluid ounces of a food gradeacidic agent, such as, distilled white vinegar or apple cider vinegar,with an acidity level of 4-6% in a 32 fluid ounce volume container. 18.In accordance with claim 1, an oral antibacterial pro-coagulantcomposition in a 32 fluid ounce by volume container further comprising:(a) between 50 milligrams and 5,000 milligrams of Niacin (B-3) dissolvedin (b) between 16 fluid ounces and 24 fluid ounces of 3% by volume ofhydrogen peroxide in purified water, and (c) further dissolved intobetween 8 fluid ounces and 12 fluid ounces of distilled or purifiedwater, (d) optionally, orally acceptable excipients (e) 1000 mg. ofcalcium carbonate, and (f) 175 IU of Vitamin D-3 further dissolved into(g) 4 fluid ounces of a food grade acidic agent, such as, distilledwhite vinegar or apple cider vinegar with an acidity level of 4-6%combined with (b) and (c) for a composition in a 32 fluid ounce byvolume container.
 19. In accordance with claims 1-14, an oralantibacterial pro-coagulant composition in the embodiment of an oralrinse that is capable or being used as an oral rinse or administered viaa power water jet flossing machine and that is administered as areplacement of, or additive to, water or other oral health liquids. 20.In accordance with claims 1-14 a method for the treatment of gum diseaseand the prevention of gingivitis comprising administering theantibacterial pro-coagulant to the gums of person in need thereof,preferably twice or more a day.
 21. In accordance with claim 1, 2, 3, 4,5, and 6, a method of treating inflamed skin, insect bite inflammation,surface skin cuts and acne conditions by applying the topical pasteapplied to the face or body topically for the facilitation of healing offacial inflammation due to bacteria-causing skin breakouts and acne. 22.In accordance with claims 1, 2, 3, 4, 5 and 6 an oral antibacterialpro-coagulant composition in the embodiment of an oral rinse, oral gel,toothpaste, gum or spray
 23. In accordance with claims 1, 2 and 9 atopical pro-coagulant paste composition further comprising: (a) between550 milligrams and 5,000 milligrams of Niacin (B-3) dissolved in (b)between 1 fluid ounce and 2 fluid ounces of 3% by volume of hydrogenperoxide in purified water, and (c) further mixed into between 1tablespoon and 2 tablespoons of Xanthan gum or other optional thickeningagent to form a stable topical paste for application to surface skincuts to stop bleeding and assist in the healing of inflamed skin due toacne.
 24. A method of treating or preventing a disease or condition ofthe oral cavity, comprising applying an oral care composition accordingto claims 1-5 to the oral cavity.
 25. A method of protecting gums fromgingivitis or periodontal disease, the method comprising applying anoral care composition according to claim 1-5 to the gum surface.
 26. Amethod of claim 14 comprising the steps of: (a) adding the compositionin accordance with claims 1-14 to a water jet flossing machine tank, (b)turning on the water jet and concentrating the water pulse irrigation onproblem gum areas first. (c) next, using the water jet to irrigate alongthe entire gum-line of both upper and lower gums, both inside and out(d) allow bacterial foaming to dissipate and expectorate the foam as itforms in the mouth, (e) rinse with distilled, purified or clean water.27. In accordance with earlier referenced claims 1-26, a method ofpromoting hair follicle growth by application of the presented inventionto a human scalp to promote blood flow to the scalp through below skinsurface blood vessel dilation and below surface anti-bacterial cleansingof the scalp effecting an unrestricted and healthy skin tissueenvironment conducive to promoting hair follicle growth.